Agency classClass IIOur severity:High FDA (Devices)·Z-0430-2013·Announced 2012-11-28

Biomerieux Recalls 0.9% Sodium Chloride Injections for VITEK 2 System Use

Biomerieux Inc is recalling 0.9% Sodium Chloride Injections that were distributed as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where the wrong concentration of sodium chloride is used for a medical diagnostic system, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Biomerieux Inc is recalling 199 cases of 0.9% Sodium Chloride Injections, USP, 1000ml (VWR/Baxter). The firm inventoried and distributed these 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system. The VITEK 2 user manual instructs users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system is designed to use only that concentration range.

The affected product is identified by Lot number C866715 with an expiration date of OCT 13. The product was distributed nationwide in the United States, including specific states such as AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VA, and WI. Distribution also extended to Canada, military facilities, and other foreign countries.

Users of the VITEK 2 system should stop using the affected 0.9% Sodium Chloride Injections and contact Biomerieux Inc for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product: 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride…
Manufacturer: Biomerieux Inc
Category: Medical Device — Diagnostic Reagents
Hazard: mis-labeling
concentration-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot number C866715
EXP OCT 13

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Same manufacturer · Biomerieux Inc

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